Flowflex Plus RSV + Flu A/B + COVID Home Test

Flowflex Plus RSV + Flu A/B + COVID Home Test is an FDA 510(k)-cleared medical device (K251749) manufactured by ACON Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 2025. Regulation: 8.